Development of Medical AI Systems in accordance with MDR & AI Act

We develop customized AI-based software solutions for companies in the healthcare industry—certified according to ISO 13485 and ISO 27001.

Our team in Munich has in-depth technical expertise in artificial intelligence – from classic machine learning methods to specialized LLMs and explainable AI.

In doing so, we ensure regulatory compliance in accordance with MDR, GDPR, and the EU AI Act.

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Our Services:
Technical Planning & Implementation

We implement AI solutions that are secure and reliable.
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Database & Data Management

We ensure a structured and cleanly versioned database—the foundation of every medical AI application. In doing so, we consistently pay attention to data quality, GDPR compliance, and transparency of data origin.
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Model Development & training

We select suitable model architectures and train them on medically valid data sets. Through targeted preprocessing and hyperparameter tuning, we achieve robust, powerful models.
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Validation & Testing

Our models undergo a systematic testing process with clear performance metrics and robustness testing. We rely on established metrics as well as bias testing and cross-validation for clinical validation.

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Explainability & Transparency

We develop explainable AI solutions that make medical decisions transparent. Interpretability, user comprehensibility, and audit trails are our focus.
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Operations & MLOps

Our infrastructure enables continuous monitoring, automatic retraining, and drift detection. This ensures that the AI application remains stable, secure, and up to date in the long term.
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Cyber Security

We integrate protection mechanisms against attacks such as data poisoning, model inversion, and extraction. We view security as an integral part of the development process.

Our Service:
Regulatory Compliance

We ensure regulatory compliance of the AI solution in all relevant aspects. This includes, among other things:
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  • Data protection in accordance with the GDPR
    (data protection impact assessment, privacy by design, data minimization, data subject rights, etc.)
  • Medical device regulations according to MDR
    (AI development taking into account ISO 13485, IEC 62304, ISO 14971, clinical evaluation according to MDR, PMS, etc.)
  • DiGA regulations according to DiGAV & SGB V
    (evidence requirements, quality of medical content, patient safety, etc.)
  • AI Act
    (Risk classification, transparency requirements, data quality, human oversight, etc.)

What really sets us apart

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ISO 13485 certified

Our quality management system is certified according to ISO 13485. This ensures that we develop software as a medical device in compliance with regulations and meet the requirements of the MDR and FDA (21 CFR) for quality management systems.
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ISO 27001 certified

QuickBird Medical is ISO 27001 certified for information security. We are experts in the areas of cybersecurity and health data protection.
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Legal Manufacturer for your Medical Device

If required, we can take on the role of legal manufacturer for your medical device software. We therefore bear legal responsibility for compliance with all regulatory requirements of the MDR. This allows you to focus on your core competencies such as sales & marketing.

About QuickBird Medical

QuickBird Medical Managing Directors Malte Bucksch and Stefan Kofler

In the heart of Munich, we develop software solutions for pharmaceutical and medtech companies, clinics, and digital health startups—customized, regulatory compliant, and certified according to ISO 13485 and ISO 27001.

Our team of 30 has built up in-depth expertise in the development of medical AI systems over many years. We have developed and trained AI models for decision support systems and integrated specialized LLMs into patient apps, for example.

Thanks to our 10 years of experience in developing medical device software, we are also familiar with the regulatory requirements that must be met when developing AI software for the medical industry, and we can help you implement these requirements safely and efficiently.

Our Guidelines on AI as a Medical Device

Social cover image for blog: AI Act: Guide for medical device manufacturers according to MDR

AI Act: Guide for Medical Device Manufacturers according to MDR

With the EU AI Act, the EU is now also regulating the use of artificial intelligence (AI). This also affects manufacturers of software medical devices who integrate AI into their MDR medical devices. The AI Act ensures that AI systems are designed in such a way that the safety and fundamental rights of individuals are protected. Find out here what manufacturers of software medical devices need to bear in mind.
Social cover image for blog: Artificial intelligence in medical devices according to MDR

Artificial Intelligence in Medical Devices – MDR Guide

With ChatGPT at the latest, artificial intelligence (AI) has become the topic of our time – also in the field of software medical products. Many manufacturers are unsure about the extent to which AI can be used in medical devices at all. For this reason, in this article we want to look at the use of artificial intelligence, in particular machine learning (ML), in regulated medical devices. In this guide, we focus on the implications of the Medical Device Regulation (MDR) for AI-based medical devices.

Do you need support with
implementing an AI software solution?

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Contact us for a no-obligation initial consultation.
We develop your customized medical AI software solution—regulatory compliant, practical, and data-driven. Our shared goal: to efficiently bring your AI application to market maturity.

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